The Hazard Analysis Risk-based Prevention Controls (HARPC) would require almost every facility that manufactures, packs, bottles or store food to identify the potential food safety risks that they face, come up with solutions to control those risks, monitor those controls and implement corrective action in the event that the controls fail. It is part of the 2011 Food Safety Modernization Act, which was passed in the wake of several well-publicized Salmonella outbreaks.

But some food producers, particularly small farms, are wondering if they will be subject to HARPC. According to the FDA, the law will not apply to farms that grow and harvest their own food, but it will kick in for farms that sell crops from other facilities, or for those who engage in manufacturing processes—which include irradiation; cutting, coring, chopping slicing; artificial ripening; distilling; and pasteurizing or homogenizing.

The White House Office of Management and Budget has estimated that the rule will cost the industry $701 million in its first year of implementation, and experts tell Food Safety News that small- and medium-sized food processors will likely be the hardest-hit by the requirements.

HARPC does exempt “small” or “very small businesses,” as defined by the FDA, from complying with regulations.